Focus on accelerated approval procedures - Will the German added benefit be reduced in the future if evidence is not provided?
In the field of oncological drugs in particular, the European Medicines Agency (EMA) is increasingly approving drugs under an accellerated approval procedure. The initial conditional medical approval is an option for drugs, whose efficacy is suspected on the basis of initial study data, however this efficacy cannot be finally assessed until ongoing confirmatory studies are completed . With accelerated procedures, severely ill patients should be given access new drugs more quickly. Pharmaceutical companies must provide the requested data within a deadline set by the EMA. The German Federal Joint Committee (G-BA) can include these requirements in its own assessment and demand that the pending data will be submitted for a later benefit assessment.
Often, however, manufacturers do not provide the promised data within the specified period, which means that they are not available to the G-BA for a comprehensive benefit assessment of the active substance. The Chairman of the G-BA, Professor Josef Hecken, now called for a more consistent action by the EMA during a seminar of the Institute for Patient-Oriented Care Process Research. In addition, it must be possible for the G-BA to punish manufacturers by way of a reduction of the added benefit, if the required data are not submitted within the requested period. However, the legislator has yet to authorise this.
Prof. Hecken also calls for an authorization of the G-BA to request inclusion of patients in a registry for certain high-priced and maximally invasive therapies. This way, the G-BA aims to more reliably quantify the effectiveness of new drugs in routine use. A related demand of the G-BA for enforcing the establishment of special patient registries for drugs against rare diseases (so-called orphan drugs) has already been laid down in a draft bill. The demand for mandatory registers is supported by the Drug Commission of the German Medical Profession and its chairman, Professor Wolf-Dieter Ludwig.
As an established strategy consultancy in the health care sector, one of our main focuses is the process of early benefit assessment according to §35a SGB V within the framework of AMNOG. SKC consulting has gained extensive experience in the design and establishment of patient registries. Please read also our publication Patient Register in the German Care Context as "Edition" in the Benefit Assessment Procedure according to §35a SGB V (German only).
BY Prof. Matthias P. Schönermark,M.D., Ph.D., managing director, Dr. Angelika Deichmann and Bianca Prelle, B.A. Health Management
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